ALLEGAN, Mich., Dec. 29 Perrigo Company (Nasdaq:PRGO; TASE) today announced that it has received final approval from the U.S.Food and Drug Administration for its Abbreviated New Drug Application (ANDA)for over-the-counter (OTC) Ibuprofen and Diphenhydramine Citrate Tablets,200/38 mg. Perrigo is expecting to begin product shipments to retailers duringthe first quarter of calendar year 2009.
The product will be marketed under store brand labels and is comparable toWyeth Consumer Healthcare's Advil(R) PM tablets, 200/38 mg, indicated as apain reliever (NSAID)/nighttime sleep-aid. Estimated brand sales for theproduct for the last 12 months ending September 28, 2008 were $70 million.
Perrigo's Chairman and CEO Joseph C. Papa stated, "We are obviouslydelighted by this latest approval, which is another example of Perrigo'scontinuing investments to make quality healthcare more affordable to Americanconsumers. Investments like this one help save OTC healthcare consumersapproximately $1 billion annually when compared to the higher priced nationalbrands."
Perrigo Company is a leading global healthcare supplier that develops,manufactures and distributes OTC and prescription pharmaceuticals, nutritionalproducts, active pharmaceutical ingredients (API) and consumer products. TheCompany is the world's largest manufacturer of OTC pharmaceutical products forthe store brand market. The Company's primary markets and locations ofmanufacturing facilities are the United States, Israel, Mexico and the UnitedKingdom. Visit Perrigo on the Internet (http://www.perrigo.com).
Note: Certain statements in this press release are forward-lookingstatements within the meaning of Section 21E of the Securities Exchange Act of1934, as amended, and are subject to the safe harbor created thereby. Thesestatements relate to future events or the Company's future financialperformance and involve known and unknown risks, uncertainties and otherfactors that may cause the actual results, levels of activity, performance orachievements of the Company or its industry to be materially different fromthose expressed or implied by any forward-looking statements. In some cases,forward-looking statements can be identified by terminology such as "may,""will," "could," "would," "should," "expect," "plan," "anticipate," "intend,""believe," "estimate," "predict," "potential" or other comparable terminology.The Company has based these forward-looking statements on its currentexpectations, assumptions, estimates and projections. While the Companybelieves these expectations, assumptions, estimates and projections arereasonable, such forward-looking statements are only predictions and involveknown and unknown risks and uncertainties, many of which are beyond theCompany's control. These and other important factors, including thosediscussed under "Risk Factors" in the Company's Form 10-K for the year endedJune 28, 2008, as well as the Company's subsequent filings with the Securitiesand Exchange Commission, may cause actual results, performance or achievementsto differ materially from those expressed or implied by these forward-lookingstatements. The forward-looking statements in this press release are madeonly as of the date hereof, and unless otherwise required by applicablesecurities laws, the Company disclaims any intention or obligation to updateor revise any forward-looking statements, whether as a result of newinformation, future events or otherwise.
SOURCE Perrigo Company